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NCT00524225
Phase II Clinical Efficacy Trial of Recombinant Interleukin-11 (rhIL-11, Neumega) in Subjects With Type 1 Von Willebrand Disease Undergoing Surgery
Phase 2 trial testing Neumega (Oprelvekin, Interleukin 11, IL-11) in Von Willebrand Disease in 3 participants. Terminated before completion.
1 June 2012
Quick facts
| Lead sponsor | Margaret Ragni |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 3 |
| Start date | 1 February 2008 |
| Primary completion | 1 June 2012 |
| Estimated completion | 1 June 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Neumega (Oprelvekin, Interleukin 11, IL-11) — full drug profile →
Conditions studied
- Von Willebrand Disease — all drugs for Von Willebrand Disease →
Sponsor
Margaret Ragni — full company profile →
Who can join
18 and older, any sex, with Von Willebrand Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Volume of Surgical Blood Loss
Time frame: 4 weeks
Hemostatic efficacy was measured by estimated blood loss (cc) during the surgical procedure. -
Volume of Blood Transfusion
Time frame: 4 weeks
The volume of blood transfusion required (units of blood) after the surgical procedure.
Sponsor's own description
The purpose of this study is to determine the efficacy and safety of rhIL-11 when given subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Interleukin 11 therapy causes acute left ventricular dysfunction.
Sweeney M, O'Fee K, Villanueva-Hayes C, Rahman E, et al · · 2024 · cited 7× · PMID 39383190 · DOI 10.1093/cvr/cvae224
Verify or expand the search:
- PubMed search for NCT00524225
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Von Willebrand Disease
Currently open trials in the same condition.
- NCT02932618 — A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Diseas · Phase 3 · recruiting
Other Margaret Ragni trials
Trials by the same sponsor.
- NCT04303572 — The Hemophilia Inhibitor Eradication Trial · Phase 3 · terminated
- NCT04303559 — The Hemophilia Inhibitor Prevention Trial · Phase 3 · terminated
- NCT02606045 — Minimize Menorrhagia in Women With Von Willebrand Disease · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00524225 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Margaret Ragni
- Last refreshed: 2 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00524225.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing